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 Universal Declaration of Human Rights

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Off Label Promotion

The FDA has pursued criminal prosecutions of corporations that do off-label promotion of prescription drugs.  In 2009, Eli Lilly agreed to pay $1.4 Billion in criminal and civil penalties for such off-label promotion of Zyprexa.  Pfizer agreed to pay $2.3 Billion for the illegal off-label promotion of Geodon and other drugs.  In 2010, Astra-Zeneca agreed to pay $520 million for the illegal off-label promotion of Seroquel for use in children, and Forest Laboratories agreed to pay $309 million for the illegal off-label promotion of the use of Lexapro and Celexa in children.  However, despite these large penalties by the drug companies, the practice of off-label has not stopped.

Although Pfizer paid $2.3 billion to settle claims associated with the off-label promotion of Bextra and three other drugs, the $16.8 billion in revenues that it earned from those drugs demonstrates how profitable  off-label marketing really is and how the risk is transferred to patients and the  healthcare system.   The profits are so high that the company knows that the proportion that they pay in fines and judgements is worth the risk.

 Neurontin®  was  FDA-approved for treating epilepsy were projected at approximately $500 million. With off-label marketing  sales went from $97.5 million to $2.7 billion by 2003, with nearly 90% of Neurontin prescriptions written for off-label uses. Neurontin’s manufacturer ultimately paid $430 million to settle civil and criminal charges associated with off-label promotion—a fraction of its increased profits from the drug’s off-label sales.

 Most off-Label marketed drugs lack clinical efficacy and less than one third of them were backed by scientific evidence.  This means that patients were subjected to unsafe drugs which were ineffective.

  • Gardiner Harris, Pfizer Pays $2.3 Billion to Settle Marketing Case, N.Y. Times (Sept. 3, 2009), http://www. nytimes.com/2009/09/03/business/03health.html.
  • Press Release, Dep’t of Justice, Warner-Lambert to Pay $430 Million to Resolve Criminal & Civil Health Care Liability Relating to Off-Label Promotion (May 13, 2004), available at http://www.justice.gov/opa/pr/2004/May/04_civ_322.htm.
  •  David C. Radley et al., Off-label Prescribing Among Office-Based Physicians, 166 Archives Internal Med. 1021, 1023 (2006), underscores this problem.

Zyprexa Drug Rep

Ex-Pharmaceutical Representative

Attorney Jim Gottstein

Psych Rights Qui Tam

http://psychrights.org/education/ModelQuiTam/ModelQuiTamPowerPoint.pdf

Lobbies Rule America

GlaxoSmithKline Whistleblower

Psych Rights

Ex-Lilly Rep

“Too often we underestimate the power of a touch, a smile, a kind word, a listening ear, an honest compliment, or the smallest act of caring, all of which have the potential to turn a life around.”
 
― Leo Buscaglia

Medical Whistleblower Advocacy Network

MEDICAL WHISTLEBLOWER ADVOCACY NETWORK

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"It is not the critic who counts; not the man who points out how the strong man stumbles, or where the doer of deeds could have done them better. The credit belongs to the man who is actually in the arena, whose face is marred by dust and sweat and blood; who strives valiantly; who errs, who comes short again and again, because there is no effort without error and shortcoming; but who does actually strive to do the deeds; who knows great enthusiasms, the great devotions; who spends himself in a worthy cause; who at the best knows in the end the triumph of high achievement, and who at the worst, if he fails, at least fails while daring greatly, so that his place shall never be with those cold and timid souls who neither know victory nor defeat."

Theodore Roosevelt- Excerpt from the speech "Citizenship In A Republic", delivered at the Sorbonne, in Paris, France on 23 April, 1910